Mintz Levin - Health Law & Policy Matters

Back to School – HIPAA 101

After a summer that saw major data breaches at the Office of Personnel Management and UCLA Health System, this fall is a great time to take your organization back to school on HIPAA compliance and data security. Here are four…more
| Consumer Protection, Health, Labor & Employment Law, Privacy, Science, Computers, & Technology

State Pharmaceutical Pricing Disclosure Laws: Old Story, New Refrain

As a veteran of the AWP litigation era, I am struck by the recent state efforts to legislate transparency into pharmaceutical pricing. Multiple states have introduced bills that would require pharmaceutical manufacturers to…more
| Consumer Protection, Elections & Politics, Health, Science, Computers, & Technology

Off-Label Marketing and the False Claims Act

In a post published earlier this week this week our colleagues Brian Dunphy and Joanne Hawana examined key issues in the recent Amarin decision from the Southern District Court of the New York. The August 7th ruling provided…more
| Administrative Law, Communications & Media Law, Government Contracting, Health, Science, Computers, & Technology

First Amendment Protects Truthful Off-Label Speech by Drug Manufacturers

Pharmaceutical manufacturers have likely taken note of Amarin Pharma Inc.’s recent success in a pre-enforcement legal challenge against the Food and Drug Administration (FDA or the Agency). On August 7, 2015, Amarin obtained a…more
| Administrative Law, Communications & Media Law, Constitutional Law, Health, Science, Computers, & Technology

FDA Cites Drug Company for Kim Kardashian Endorsement

This week might have been the first time that an FDA regulatory issue hit the headlines on TMZ and other “celebrity watcher” websites. In an August 7 Warning Letter sent to the drug company Duchesnay, Inc., FDA complains that a…more
| Administrative Law, Communications & Media Law, Consumer Protection, Health, Science, Computers, & Technology

Drug Pumps Are Vulnerable to Hacking, FDA Warns

Last Friday, the Food and Drug Administration (FDA) issued a statement warning that certain drug infusion pumps that administer medication to patients are vulnerable to being hacked. The statement focused on the Symbiq Infusion…more
| Health, Science, Computers, & Technology

OIG Issues Favorable Advisory Opinion of Hospital Leasing Arrangement

Last week, the Office of Inspector General (OIG) for the Department of Health and Human Services published Advisory Opinion 15-10 (Opinion). The Opinion addressed a hospital system’s proposal to lease non-clinician employees and…more
| Health

The Corporate Practice Prohibition in New York: What We Can Learn From the ADMI Settlement

One of the most frequently asked questions posed to healthcare lawyers is whether State X has a prohibition on the corporate practice of medicine, nursing or other profession, and if so, whether the prohibition is enforced. As…more
| Health

Emerging State Biosimilar Laws – Reference Chart and Five Issues to Watch

As we’ve previously discussed, states have begun to actively regulate the substitution of interchangeable biosimilars before any FDA-approved biosimilar has even hit the market. State biosimilar legislation passed to date has…more
| Health, Science, Computers, & Technology

FCC Ruling Addresses Robocalls by Health Care Providers

Mintz Levin’s Communications Practice recently released a Communications Advisory discussing a Declaratory Ruling and Order released by the Federal Communications Commission (FCC). The ruling clarified and expanded the reach of…more
| Communications & Media Law, Consumer Protection, Health, Privacy

Class Action Suit Filed Against UCLA After It Suffers Massive Data Breach Affecting 4.5 Million Individuals

In yet another data breach affecting millions of individuals, UCLA Health System (“UCLA”) reported on July 17, 2015, that hackers had accessed portions of its health network that contained personal information, including names,…more
| Consumer Protection, Health, Privacy, Science, Computers, & Technology

Government Finalizes Religious Accommodation, But What About Health Plans, TPAs and PBMs?

In a set of rules published last week, the government finalized a July 2010 interim final rule (“IFR”) related to coverage of certain preventive services and an August 2014 IFR regarding the definition of an eligible…more
| Health, Labor & Employment Law

Trinity Homecare Settlement: Five False Claims Trends

New York State Attorney General Eric Schneiderman recently announced that his office had reached a $2.5 million settlement in a federal False Claims Act (FCA) case with Trinity HomeCare and its related entities. The case, filed…more
| Civil Procedure, Health

American Academy of Pediatrics Recommends Limits on Telemedicine

On June 29, 2015, the American Academy of Pediatrics (AAP) published a policy statement supporting the use of telemedicine in the practice of pediatrics as long as telemedicine technologies are used “in support of and integrated…more
| Health

Delivery System Reform 2.0: Scaling Alternative Payment Models is the New Normal

For some health care providers, a pair of recent announcements made by the Obama Administration to implement mandatory alternative payment models (APMs) for home health value-based purchasing and bundled payments for hip and…more
| Health
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Contact

701 Pennsylvania Avenue, N.W.
Washington, DC 20004-2608, United States

  • 202-434-7324
  • 202-434-7400

Areas of Practice
  • Administrative Law
  • Commercial Law & Contracts
  • Health
  • Litigation
  • Mergers & Acquisitions
  • Securities Law
Locations
Other U.S. Locations
  • California
  • Connecticut
  • D.C.
  • Massachusetts
  • New York
Other Countries
  • Israel
  • United Kingdom
Number of Attorneys

25-50 Attorneys

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